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Completed

NCT Number: NCT00671944

Long-term Nutritional Intervention Study to Determine How Protein Affects Calcium Metabolism

Osteoporosis is a major health problem in men and women in this country and the incidence of this disease is rising. We think that environmental factors such as nutrition may play a role in the increasing prevalence of osteoporosis. In particular, we think that a diet that is too low in protein may be contributing to bone loss. The primary purpose of this study is to compare the long-term impact of a low protein diet on measures of bone and calcium metabolism.

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Key information

Age range

20 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Yale New Haven Hospital Research Unit

New Haven, Connecticut, 06510, United States

About this study

The protocol is composed of a 9.5-week study, consisting of a 3-week adjustment period followed by a 6.5-week experimental period. During the adjustment period, subjects consume a well-balanced lead-in diet designed to stabilize baseline Ca homeostasis. In the subsequent experimental period, subjects will consume the experimental diet containing 0.7 g protein/kg, 800-1200 mg phosphorus, 800 mg calcium and 2300 mg sodium. During days -6 to -1 of the adjustment diet, 5-10 and days 40-45 of the experimental period, we will measure Ca absorption and kinetics. Weekly assessments of Ca homeostasis will be done using our standard measures of calcitropic hormones, markers of bone turnover, and urine and serum minerals.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy Asian or Caucasian women between the ages of 20-40 years.

Exclusion criteria

  • Diseases or medical conditions: gastrointestinal diseases, osteoporosis, diabetes, hypertension, liver disease, thyroid disorders, kidney disease, kidney stones, cancer, heart disease, eating disorders, obesity, hypogonadism , amenorrhea, oligomenorrhea, abnormal serum FSH or estradiol levels, birth control medication, or other hormone-altering medications, pregnancy.
  • Lifestyle: smoking, excessive exercise (although moderate exercise is allowed), prescription medications known to influence vitamin D or calcium metabolism or gastric acid, excessive body weight change during the past 6 months, food allergies, unusual eating habits, or medically prescribed diets.
  • Also excluded are prisoners and individuals who are cognitively impaired.

Treatment and study plan

Low protein diet

Other

Low protein diet for 6.5 weeks

Primary outcomes

  1. Calcium absorption and kinetics

    Time frame: Baseline, day 5 and week 6

Secondary outcomes

  1. Serum Parathyroid hormone

    Time frame: baseline and weekly

  2. Markers of bone turnover

    Time frame: baseline and weekly

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • United States Department of Agriculture (USDA)

Registry information

Official study title

Long-term Impact of Protein on Calcium Kinetics

Important dates

Study start
2003
Primary completion
2009
Study completion
2010
First posted
May 5, 2008
Registry last updated
Mar 31, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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